Drug product
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,
D-0896-2023
Product summary
- Firm
- Vivus, Inc.
- Event
- Event 92582
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4240 bottles
- Official record key
drug-enforcement:D-0896-2023
Official wording
Reason: Failed Stability Specifications
Code information: Lot #: 102101, Exp: 31 July 2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications